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Satisfaction & Efficacy of Compression Using Surgical Gloves in Chemo-induced Peripheral Neuropathies (ELEGANT)

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ClinicalTrials.gov Identifier: NCT03872908
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief Summary:
Evaluation of Satisfaction & Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Due to Chemotherapy

Condition or disease Intervention/treatment
Breast Cancer Colorectal Cancer Device: Chilled gloves Device: Surgical gloves

Detailed Description:

Peripheral neuropathy (PN) is an adverse event of numerous chemotherapy agents commonly used, including taxanes (paclitaxel, docetaxel) and platinum-based treatments (oxaliplatine, cisplatine, carboplatine).

Taxanes are widely used in breast cancer. Docetaxel and paclitaxel became indispensable during the last decade in metastatic and early stage breast cancer treatment. For platinum-based chemotherapies, oxaliplatine is one of the main molecules used in digestive oncology, particularly in colorectal cancer.

The limiting toxicities of taxanes and platinum-based treatments which can lead to the therapeutic scheme modification (therefore to a potential diminution of efficacy and eventually to treatment stop) are mainly hematologic (neutropenia) and neurological, the most frequent neuro-toxicity event being a PN associated or not to neuropathic pains. The PN induced by chemotherapy can occur prematurely during the treatment course, persist between the treatments' cycles and last a long time after the end of cycles, with an impact on patients' quality of life. Symptoms are mainly sensitive, including pain, paresthesia and hands / foot numbness. These symptoms, as the hematologic toxicity, represent a major limiting factor for the treatment.

According to the ASCO recommendations, there is no effective prophylactic method against the chemo-induced PN. In a retrospective study, the chilled gloves used for preventing the nail lesions during chemotherapy may reduce the incidence of docetaxel-induced PN. Recently, the surgical gloves efficacy against paclitaxel-induced PN has been evaluated prospectively in women presenting a metastatic or early stage breast cancer, with a percentage of grade >=2 NP significantly lower for the hand protected by surgical gloves than the control hand without glove (compression-induced vasoconstriction responsible for a blood flow reduction in the hands and therefore for the local exposure to chemotherapy agents) and a good tolerance.

Chilled gloves, which use the same principle of vasoconstriction through cold, are also used in the current practice for preventing the PN occurrence. However, contrary to surgical gloves, they can be not well tolerated since the very first cycles (intolerance to cold sensation).

The objective of this study is to evaluate the medium and long term efficacy of compression induced by surgical gloves against the PN development in two frequent indications in oncology, patients treated with paclitaxel (breast cancer) or oxaliplatine (colorectal cancer) and patients' satisfaction.


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Study Type : Observational
Estimated Enrollment : 151 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Monocentric Study Evaluating Patients' Satisfaction and Efficacy of Compression Using Surgical Gloves in Peripheral Neuropathies Induced by Taxane or Platinum-based Chemotherapies
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort 1
Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) versus chilled gloves (non-dominant hand) at the end of paclitaxel administration.
Device: Chilled gloves
Chilled glove for non-dominant hand (patients treated with paclitaxel)

Device: Surgical gloves
Surgical gloves (patients treated with oxaliplatine)

Cohort 2
Evaluation of the efficacy of the compression induced by surgical gloves against peripheral neuropathies in patients treated by oxaliplatine after a 595 mg/m2 cumulated dose.
Device: Surgical gloves
Surgical gloves (patients treated with oxaliplatine)




Primary Outcome Measures :
  1. Cohort1:Evaluation of patient's satisfaction when wearing surgical gloves (dominant hand) and chilled gloves (non-dominant hand) at the end of paclitaxel administration. [ Time Frame: At the end of paclitaxel administration (4 to 6 months after inclusion) ]
    Global patient's satisfaction evaluated for each hand using a numeric scale from 0 (very unsatisfied) to 10 (very satisfied)

  2. Cohort 2: Efficacy of compression induced by surgical gloves vs peripheral neuropathies development in patients treated by oxaliplatine after a cumulative dose of 595 mg/m2 [ Time Frame: After the end oxaliplatine administration (4 to 6 months after inclusion) ]
    Percentage of NP grade >= 2 after a cumulative dose of 595 mg/m2 using NCI-CTCAE v5


Secondary Outcome Measures :
  1. Cohort 1: Evaluation of comfort and pain felt with gloves for each hand [ Time Frame: At the end of each cycle (each cycle is 7 days) ]
    Evaluation using a numeric scale from 0 (Very uncomfortable / Painful) to 10 (Very comfortable / No pain)

  2. Evaluation of the ease to put on gloves for each hand [ Time Frame: At the end of paclitaxel administration (4 to 6 months) ]
    Evaluation using a numeric scale from 0 (Very difficult / long) to 10 (Very easy / Fast)

  3. Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand [ Time Frame: Before each cycle (except the 1st one), (each cycle is 7 days) ]
    Evaluation using NPSI and MRC questionnaires

  4. Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand [ Time Frame: At the end of paclitaxel administration (4 to 6 months after inclusion) ]
    Evaluation using NPSI and MRC questionnaires

  5. Cohort 1: Evaluation of the percentage of motor and sensitive peripheral neuropathies for each hand [ Time Frame: 12 months after the end of treatment ]
    Evaluation using NPSI and MRC questionnaires

  6. Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand [ Time Frame: Before each cycle (except the 1st one) (each cycle is 7 days) ]
    Evaluation using the NCI-CTCAE v5 scale

  7. Cohort 1: Evaluation of the percentage of peripheral neuropathies >= 2 for each hand [ Time Frame: At the end of paclitaxel administration (4 to 6 months after inclusion) ]
    Evaluation using the NCI-CTCAE v5 scale

  8. Cohort 1: Evaluation of the percentabe of onycholysis grade 2 for each hand [ Time Frame: At the end of paclitaxel administration (4 to 6 months after inclusion) ]
    Evalutation using NCI-CTCAE v5 scale

  9. Cohort 1: Evaluation of nurses's preference for the gloves wearing (surgical versus chilled gloves) [ Time Frame: At the end of paclitaxel administration (4 to 6 months after inclusion) ]
    Evaluation using a numeric scale from 0 (Very xxxx) to 10 (Very xxxx)

  10. Cohort 2: Evaluation of the global satisfaction concerning surgical gloves wearing, comfort, pain and ease to wear [ Time Frame: At the end of oxaliplatine administration (4 to 6 months after inclusion) ]
    Evaluation using a numeric scale from 0 (Very unsatisfied) to 10 (Very satisfied)

  11. Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand [ Time Frame: Before each cycle (except the 1st one) (each cycle is 7 days) ]
    Evaluation using a duration questionnaire

  12. Cohort 2: Evaluation of the acute sensitive peripheral neuropathies for each hand [ Time Frame: At the end of oxaliplatine administration (4 to 6 months after inclusion) ]
    Evaluation using a duration questionnaire

  13. Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand [ Time Frame: After each cycle (except the 1st one), (each cycle is 7 days) ]
    Evaluation using the NPSI questionnaire

  14. Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand [ Time Frame: At the end of oxaliplatine administration (4 to 6 months after inclusion) ]
    Evaluation using the NPSI questionnaire

  15. Cohort 2: Evaluation of the peripheral neuropathies percentage for each hand [ Time Frame: 12 months after the end of treatment. ]
    Evaluation using the NPSI questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with adjuvant or metastatic:

  • Breast cancer treated by Paclitaxel or,
  • Colorectal cancer treated by Oxaliplatine
Criteria

Inclusion Criteria:

  • Age >= 18 years old
  • Breast cancer requiring a treatment by paclitaxel or colorectal cancer requiring a treatment by oxaliplatine
  • At least 8 chemotherapy cycles planned
  • Able to understand, read and write French language
  • Covered by a social insurance
  • Dated and signed informed consent

Exclusion Criteria:

  • Pre-existing neuropathy or history of neuropathy
  • Psychological, family, sociological or georgraphical condition that may potentially compromise the adherence to study protocol and follow up
  • Cohort 1: Patients presenting a Raynaud's syndrome (contra-indication to cold temperatures)
  • Participation to clinical trial which may interfere with the evaluation of the main endpoints.
  • Pregnant or breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872908


Contacts
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Contact: Thomas BACHELOT, MD +33 4.78.78.26.54 thomas.bachelot@lyon.unicancer.fr
Contact: Aurélia CHABERT +33 4.78.78.27.08 aurelia.joureau@lyon.unicancer.fr

Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Thomas BACHELOT, MD Centre Leon Berard

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT03872908     History of Changes
Other Study ID Numbers: ET18-262 ELEGANT
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
Breast cancer
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuromuscular Diseases
Nervous System Diseases